Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 6:43 PM
Study NCT ID:
NCT03771859
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-09-14
First Post:
2018-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RFS (relapse free survival)', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'DMFS (distant metastasis free survival)', 'timeFrame': '5 years'}, {'measure': 'OS (overall survival)', 'timeFrame': '5 years'}, {'measure': 'Distribution of sociodemographic characteristics in participants initiating nivolumab', 'timeFrame': '5 years'}, {'measure': 'Distribution of clinical characteristics in participants initiating nivolumab', 'timeFrame': '5 years'}, {'measure': 'Distribution of treatment patterns in participants initiating nivolumab', 'timeFrame': '5 years'}, {'measure': 'QOL (quality of life) of patients with resected melanoma receiving adjuvant nivolumab therapy by using the EuroQOL-5D (EQ-5D)', 'timeFrame': '5 years', 'description': 'The EQ-5D is a standardized 3-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, where each dimension is rated by individuals as no problems, slight problems, moderate problems, severe problems, and extreme problems.'}, {'measure': 'The European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire', 'timeFrame': '5 years', 'description': 'The EORTC-QLQ-C30 questionnaire is a 30-item instrument that comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).'}, {'measure': 'Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaires', 'timeFrame': '5 years', 'description': 'The FACT-M is a frequently used melanoma specific questionnaire which has been validated to assess HRQOL for patients with all stages of melanoma. Besides general questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being, it also contains specific questions related to melanoma, including a subscale on the melanoma surgery'}, {'measure': "Incidence of AE's", 'timeFrame': '5 years'}, {'measure': "Incidence of SAE's", 'timeFrame': '5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'An observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.', 'detailedDescription': 'Participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, and who receive adjuvant nivolumab under real-world conditions in Belgium or Luxembourg. Patients will be enrolled after complete surgical resection and following a screen procedure (according to standard practice) that shows no evidence of disease. Patients currently enrolled in an interventional clinical trial will not be eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease.\n* Decision to treat with adjuvant nivolumab therapy has already been taken\n* At least 18 years of age at the time of treatment decision\n* Patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought)\n\nExclusion Criteria:\n\n* Any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab\n* Any patient currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for Overall Survival (OS)/ Relapse Free Survival (RFS) can be enrolled. In case of a blinded study, the treatment arm needs to be known).\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03771859', 'briefTitle': 'A Study of Patients Receiving Adjuvant Nivolumab Therapy for Melanoma That Has Been Removed', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma', 'orgStudyIdInfo': {'id': 'CA209-8RX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants who initiate adjuvant treatment with nivolumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '5004', 'city': 'Bouge', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.47193, 'lon': 4.89218}}, {'zip': 'B-8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '2300', 'city': 'Turnhout', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'zip': '1210', 'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}